MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.0 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0300150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	09/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.
Event or Problem Description
It was reported that following angioplasty with the balloon catheter, a stent (subject device) was placed across the 76% stenosed right middle cerebral artery (mca) m1 lesion.The procedure was completed successfully with the improvement in the luminal diameter.Post procedure, the following day the patient complained of difficulty lifting left lower extremity from bed.The physician assessed the patient's ability to lift the left leg and the strength of the leg as 4+.The fluid bolus (unspecified) was administered to treat the patient.This event was resolved without any residual effect.The patient was discharged home with the modified rankin scale (mrs) score of 0.As per the physician's opinion the patient's outcome is related to the procedure however it is unknown if it is related to the device.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, neurological/intracranial sequelae is a known risks associated with endovascular procedure and are noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that following angioplasty with the balloon catheter, a stent (subject device) was placed across the 76% stenosed right middle cerebral artery (mca) m1 lesion.The procedure was completed successfully with the improvement in the luminal diameter.Post procedure, the following day the patient complained of difficulty lifting left lower extremity from bed.The physician assessed the patient¿s ability to lift the left leg and the strength of the leg as 4+.The fluid bolus (unspecified) was administered to treat the patient.This event was resolved without any residual effect.The patient was discharged home with the modified rankin scale (mrs) score of 0.As per the physician¿s opinion the patient¿s outcome is related to the procedure however it is unknown if it is related to the device.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.0 X 15MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6054377
• Report Number: 3008881809-2016-00233
• Device Sequence Number: 11221958
• Product Code: NJE
• UDI-Device Identifier: 04546540722805
• UDI-Public: (01)04546540722805(17)180630(10)18451555
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: M003WS0300150
• Device Lot Number: 18451555
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 02/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GATEWAY BALLOON (BOSTON SCIENTIFIC)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR